Eyestem Research, India’s leading cell therapy company, announces the successful completion of its dose-ranging study in animals for Eyecyte-RPE. Eyecyte-RPE is a suspension of Retinal Pigment Epithelium Cells for treatment of Dry Age-Related Macular Degeneration. 170 M people worldwide suffer from this disease, 40 M of which are in India. Eyestem Research is one of the few companies in the world to develop such a treatment.
Commenting on the positive developments, Dr Rajarshi Pal, Co-Founder and Chief Scientist, Eyestem Research, said, “We are thrilled to get a positive outcome from the dose-ranging study with our collaborators in Oregon. When injected into an inherited rat model with retinal degeneration, Eyecyte-RPE supported vision rescue demonstrated by a whole range of histological, functional and behavioural tests and helps retain the structural integrity of the host retina. These results will allow us to move forward with final manufacturing followed by toxicity studies and start human studies in the last quarter of 2022”.
“We are happy to have partnered with the Eyestem team for efficacy and safety studies of their RPE product. The current results reaffirm the results reported in 2018-19 and point to a precise roadmap for the final product formulation which would be optimum for efficacy and safety in humans. The Casey Eye team is delighted to have played a role in advancing this therapy which has tremendous potential to transform lives,” commented Dr Renee Ryals, Principal Investigator, Casey Eye Institute, Oregon Health and Science University.
“Over the next 10 years, diseases that were considered incurable will start becoming curable with the advance of cell and gene therapies. To ensure that the benefit of such therapies reaches the bottom 99 % of humanity, it is imperative to create a scalable cell therapy platform to help democratize access. Eyestem Research was purpose-built around this mission and it gives me great pleasure to see us at the cusp of human trials for our flagship product,” Commented Dr Jogin Desai, Founder and CEO, Eyestem Research.
Founded by a highly experienced management team consisting of ophthalmology, regenerative medicine and clinical trial experts, Eyestem has created a platform for allogeneic, scalable cell therapy.
While Eyecyte-RPE, the company’s patented flagship product, is close to finding a treatment for Dry AMD, the company has two more products in the pipeline for Retinitis Pigmentosa and Idiopathic
Pulmonary Fibrosis – similar incurable diseases affecting humanity. The company has received several awards and grants from the Department of Biotechnology, Government of India, published multiple papers in prestigious journals and has been awarded a patent for its unique protocol in India as well as the US.
Last year, the company received manufacturing approval for EyecyteRPE from the Indian regulators and is in the process of manufacturing the product for confirmatory efficacy and toxicity studies in animals. First, human clinical trials for Eyecyte-RPE are currently scheduled for the last quarter of 2022.